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Decree relating to the RIHN framework reform published in France
On March 31, 2024, the Ministry of Labor, Health, and Solidarity published a Decree in the Official Journal of the French Republic relating to the conditions of coverage of innovative tests within the RIHN framework. The Decree defined eligibility criteria for the framework, provided details about collecting clinical and economic data, conditions for coverage, and the possibility for direct applications by the manufacturer, but also introduced a limitation on the duration of coverage to six years. As per earlier provisions of RIHN reform announced at the end of 2022, the French National Authority for Health now has a clearly defined role in the process and should evaluate an innovative test for inclusion into the NABM Nomenclature before the coverage period expires (i.e., the transition of a test from RIHN to NABM Nomenclature).
The Decree came into force the day after its publication.
More details can be found in French here.
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